Q1: Should the frequency for the direct observation verification of monitoring
activities be listed in the HACCP plan?
A1: Yes. 9 CFR 417.2 (c)(7) requires the HACCP plan to list the verification procedures and the
frequency with which those procedures are performed. Direct observation of the monitoring activities is one of the
verification procedures listed in 9 CFR 417.4(a)(2).
Q2: Is an establishment that handles box-in,
box-out (pass through) product required to perform pre-shipment review?
A2: No. Because pass through product is not prepared or processed, no HACCP plan is required.
Thus, there are no records associated with the production of the product for the plant to perform a pre-shipment review.
Q3: Is the selection of CCPs up to the
establishment or can FSIS dictate the selection of the CCPs?
A3: The development and selection of CCPs is the establishment's responsibility. The CCPs should be
selected based on the decisions made during the hazard analysis. 9 CFR 417.5(a)(2) requires the establishment to have
decision-making documents associated with the selection and development of CCPs. FSIS should not dictate the selection of CCPs.
FSIS may raise questions about the decision-making documents and, accordingly, establishment's decisions on whether a hazard
is reasonably likely to occur. FSIS may also publish a Federal Register
Notice asking all establishments to reassess their HACCP plans for a particular hazard if FSIS becomes aware of new information.
Q4: Does a HACCP training certification expire?
Is there any requirement that establishment employees participate in continuing education?
A4: HACCP training certificates do not expire and there are no regulatory
requirements in 9 CFR 417.7 addressing continuing education.
Q5: What are the HACCP record retention requirements for ready-to-eat products?
A5: HACCP records for refrigerated ready-to-eat products are required to be retained for at least one year.
HACCP records for ready-to-eat frozen,
preserved, or shelf-stable products are required to be retained for at least two years. [9 CFR 417.5(e)].